GUDID Data Submission Compliance Update

OMEDtechNews & Events

The unique device identification (UDI) rule is being implemented by device classification, with varying compliance dates to the Global Unique Device Identification Database (GUDID).  The GUDID system was temporarily taken offline on August 7, 2015 for security reasons.  Since the system was unavailable the FDA has decided to extend the September 24, 2015 compliance date for the implantable, life-supporting and … Read More

Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview

OMEDtechDraft Guidance

The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA.  A UDI is required to be directly marked onto a device if it is “intended to be used more than once and reprocessed before each use.” (FDA)  Directly marking a UDI on reprocessed devices helps to maintain accurate information and keeps the UDI in contact with … Read More

Electronic Medical Device Reporting

OMEDtechNews & Events

Electronic Medical Device Reporting (eMDR) requires medical device manufactures and importers to submit medical device reports (MDRs) in an appropriate electronic format so the information can then be processed, reviewed, and archived by the FDA. The eMDR final rule will be effective on August 14, 2015. There are two options for submitting eMDRs: eSubmitter or Health Level 7 Individual Case … Read More

AccessGUDID Open for Public Use

OMEDtechNews & Events

AccessGUDID is now open for public use.  The FDA has released data for devices with unique device identifiers (UDI) to the public through a website called AccessGUDID. The FDA’s final guidance in 2013 explains the UDI purpose and requirements.  A UDI must be included on most device labels and packages, and device identification information must be submitted to the FDA’s Global Unique Device … Read More

Procedures for Meetings of the Medical Devices Advisory Committee

OMEDtechDraft Guidance

The CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015.  This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels.  Panel meetings provide an opportunity for addressing scientific, clinical, or public health issues. Medical Device Advisory Committee Panels functions: Panels may give expertise for medical device premarket submissions … Read More

MDDS, Medical Image Storage Devices, & Medical Image Communications Devices Final Guidance

OMEDtechGuidance

The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More

General Wellness: Policy for Low Risk Devices

OMEDtechDraft Guidance

The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.”  A general wellness product must either help to maintain a general state of health, or help to reduce the risk or … Read More

UDI Update

OMEDtechNews & Events

The FDA’s Center for Devices and Radiological Health (CDRH) has issued an update on the upcoming Unique Device Identifier (UDI) requirements. Upcoming compliance dates for UDI requirements are: September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices September 24, 2016 for class II devices Upcoming dates for Global Unique Device Identification Database (GUDID) Data Submission: January 2015, they will … Read More